Occlusive device with expandable member

ABSTRACT

An example medical device for occluding the left atrial appendage includes an expandable member having a first end region, a second end region and an inflation cavity. The medical device also includes a plurality of spine members coupled to the expandable member, the plurality of spine members spaced circumferentially around an outer surface of the expandable member. Additionally, the medical device includes a valve member extending at least partially into the inflation cavity, wherein the plurality of spine members are configured to position the medical device within an opening of the left atrial appendage and wherein the expandable member is configured to expand and seal the opening of the left atrial appendage.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. § 119 toU.S. Provisional Application Ser. No. 62/607,053, filed Dec. 18, 2017,the entirety of which is incorporated herein by reference.

BACKGROUND

The left atrial appendage (LAA) is a small organ attached to the leftatrium of the heart as a pouch-like extension. In patients sufferingfrom atrial fibrillation, the left atrial appendage may not properlycontract with the left atrium, causing stagnant blood to pool within itsinterior, which can lead to the undesirable formation of thrombi withinthe left atrial appendage. Thrombi forming in the left atrial appendagemay break loose from this area and enter the blood stream. Thrombi thatmigrate through the blood vessels may eventually plug a smaller vesseldownstream and thereby contribute to stroke or heart attack. Clinicalstudies have shown that the majority of blood clots in patients withatrial fibrillation are found in the left atrial appendage. As atreatment, medical devices have been developed which are positioned inthe left atrial appendage and deployed to close off the ostium of theleft atrial appendage. Over time, the exposed surface(s) spanning theostium of the left atrial appendage becomes covered with tissue (aprocess called endothelization), effectively removing the left atrialappendage from the circulatory system and reducing or eliminating thenumber of thrombi which may enter the blood stream from the left atrialappendage. A continuing need exists for improved medical devices andmethods to control thrombus formation within the left atrial appendageof patients suffering from atrial fibrillation.

SUMMARY

This disclosure provides design, material, manufacturing method, and usealternatives for medical devices. An example medical device foroccluding the left atrial appendage includes an expandable member havinga first end region, a second end region and an inflation cavity. Themedical device also includes a plurality of spine members coupled to theexpandable member, the plurality of spine members spacedcircumferentially around an outer surface of the expandable member.Additionally, the medical device includes a valve member extending atleast partially into the inflation cavity, wherein the plurality ofspine members are configured to position the medical device within anopening of the left atrial appendage and wherein the expandable memberis configured to expand and seal the opening of the left atrialappendage.

Alternatively or additionally to any of the embodiments above, whereineach of the spine members extends along a longitudinal axis of themedical device from the first end region to the second end region.

Alternatively or additionally to any of the embodiments above, whereinthe second end region includes a bottom surface and wherein at least aportion of each of the spine members is positioned along the bottomsurface.

Alternatively or additionally to any of the embodiments above, whereinthe expandable member includes a curved portion extending radiallyinward toward the longitudinal axis, and wherein the curved portion isconfigured to nest with the opening of the left atrial appendage.

Alternatively or additionally to any of the embodiments above, whereineach of the spine members is positioned along an outer surface of theexpandable member.

Alternatively or additionally to any of the embodiments above, wherein aportion of each of the spine members extends into the wall of theexpandable member.

Alternatively or additionally to any of the embodiments above, whereinthe first end region of the expandable member extends toward alongitudinal axis of the medical device to form an apex.

Alternatively or additionally to any of the embodiments above, whereinthe second end region includes a coating, and wherein the coating isdesigned to promote endothelial cell growth.

Alternatively or additionally to any of the embodiments above, furthercomprising a fixation member configured to anchor the medical device toa target tissue site of the left atrial appendage.

Alternatively or additionally to any of the embodiments above, whereinthe fixation member includes a plurality of bristles projecting awayfrom an outer surface of the expandable member.

Alternatively or additionally to any of the embodiments above, whereinthe fixation member includes a barb projecting away from an outersurface of the expandable member.

Another example medical device for occluding the left atrial appendageincludes:

an expandable balloon including an outer surface and an inner expansioncavity;

a plurality of positioning members coupled to the expandable balloon;

a fixation member extending away from the outer surface of theexpandable balloon;

wherein the plurality of positioning members are configured to positionthe medical device within an opening of the left atrial appendage;

wherein the expandable balloon is configured to expand and seal theopening of the left atrial appendage.

Alternatively or additionally to any of the embodiments above, whereineach of the positioning members extends along a longitudinal axis of theballoon from a first end region of the balloon to a second end region ofthe balloon.

Alternatively or additionally to any of the embodiments above, whereinthe second end region of the balloon includes a bottom surface andwherein at least a portion of each of the positioning members ispositioned along the bottom surface.

Alternatively or additionally to any of the embodiments above, whereineach of the positioning members is embedded within a wall of theballoon.

Alternatively or additionally to any of the embodiments above, whereinthe second end region includes a coating, and wherein the coating isdesigned to promote endothelial cell growth.

Alternatively or additionally to any of the embodiments above, whereinthe fixation member includes a plurality of bristles projecting awayfrom an outer surface of the balloon.

Alternatively or additionally to any of the embodiments above, whereinthe fixation member includes a barb projecting away from an outersurface of the balloon.

An example method for sealing the left atrial appendage includes:

advancing an expandable occluder to a position adjacent the left atrialappendage, wherein the expandable occluder includes:

-   -   an expandable balloon including an inflation cavity;    -   a plurality of spine members coupled to the balloon, wherein the        spine members are spaced circumferentially around an outer        surface of the expandable balloon; and    -   a valve member extending at least partially into the inflation        cavity;

inserting a tubular member into the valve;

passing an inflation media through the tubular member into the valve;and

inflating the expandable member to a first position such that theplurality of spine members position the occluder within an opening ofthe left atrial appendage.

Alternatively or additionally to any of the embodiments above, furthercomprising:

inflating the expandable member to a second position in which theexpandable member seals against an inner surface of the left atrialappendage.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present disclosure.The Figures, and Detailed Description, which follow, more particularlyexemplify these embodiments

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description of various embodiments in connection withthe accompanying drawings, in which:

FIG. 1 is a plan view of an example occlusive implant;

FIG. 2 shows a bottom view of the example occlusive implant shown inFIG. 1;

FIG. 3 shows a cross-sectional view along line 3-3 of FIG. 1;

FIG. 4 shows a cross-sectional view of another example occlusiveimplant;

FIG. 5 shows an example occlusive implant positioned in an opening ofthe left atrial appendage;

FIGS. 6-10 illustrate an example occlusive implant being positionedwithin an opening of the left atrial appendage;

FIG. 11 illustrates another example occlusive implant;

FIG. 12 illustrates another example occlusive implant including fixationmembers;

FIG. 13 illustrates another example occlusive implant;

FIG. 14 illustrates a top view of the occlusive implant shown in FIG.13.

While aspects of the disclosure are amenable to various modificationsand alternative forms, specifics thereof have been shown by way ofexample in the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit aspects of thedisclosure to the particular embodiments described. On the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the disclosure.

DETAILED DESCRIPTION

The following description should be read with reference to the drawings,which are not necessarily to scale, wherein like reference numeralsindicate like elements throughout the several views. The detaileddescription and drawings are intended to illustrate but not limit theclaimed disclosure. Those skilled in the art will recognize that thevarious elements described and/or shown may be arranged in variouscombinations and configurations without departing from the scope of thedisclosure. The detailed description and drawings illustrate exampleembodiments of the claimed disclosure. However, in the interest ofclarity and ease of understanding, while every feature and/or elementmay not be shown in each drawing, the feature(s) and/or element(s) maybe understood to be present regardless, unless otherwise specified.

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about”, in thecontext of numeric values, generally refers to a range of numbers thatone of skill in the art would consider equivalent to the recited value(e.g., having the same function or result). In many instances, the term“about” may include numbers that are rounded to the nearest significantfigure. Other uses of the term “about” (e.g., in a context other thannumeric values) may be assumed to have their ordinary and customarydefinition(s), as understood from and consistent with the context of thespecification, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numberswithin that range, including the endpoints (e.g., 1 to 5 includes 1,1.5, 2, 2.75, 3, 3.80, 4, and 5).

Although some suitable dimensions, ranges, and/or values pertaining tovarious components, features and/or specifications are disclosed, one ofskill in the art, incited by the present disclosure, would understanddesired dimensions, ranges, and/or values may deviate from thoseexpressly disclosed.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise. It isto be noted that in order to facilitate understanding, certain featuresof the disclosure may be described in the singular, even though thosefeatures may be plural or recurring within the disclosed embodiment(s).Each instance of the features may include and/or be encompassed by thesingular disclosure(s), unless expressly stated to the contrary. Forsimplicity and clarity purposes, not all elements of the disclosure arenecessarily shown in each figure or discussed in detail below. However,it will be understood that the following discussion may apply equally toany and/or all of the components for which there are more than one,unless explicitly stated to the contrary. Additionally, not allinstances of some elements or features may be shown in each figure forclarity.

Relative terms such as “proximal”, “distal”, “advance”, “retract”,variants thereof, and the like, may be generally considered with respectto the positioning, direction, and/or operation of various elementsrelative to a user/operator/manipulator of the device, wherein“proximal” and “retract” indicate or refer to closer to or toward theuser and “distal” and “advance” indicate or refer to farther from oraway from the user. In some instances, the terms “proximal” and “distal”may be arbitrarily assigned in an effort to facilitate understanding ofthe disclosure, and such instances will be readily apparent to theskilled artisan. Other relative terms, such as “upstream”, “downstream”,“inflow”, and “outflow” refer to a direction of fluid flow within alumen, such as a body lumen, a blood vessel, or within a device.

The term “extent” may be understood to mean a greatest measurement of astated or identified dimension, unless the extent or dimension inquestion is preceded by or identified as a “minimum”, which may beunderstood to mean a smallest measurement of the stated or identifieddimension. For example, “outer extent” may be understood to mean amaximum outer dimension, “radial extent” may be understood to mean amaximum radial dimension, “longitudinal extent” may be understood tomean a maximum longitudinal dimension, etc. Each instance of an “extent”may be different (e.g., axial, longitudinal, lateral, radial,circumferential, etc.) and will be apparent to the skilled person fromthe context of the individual usage. Generally, an “extent” may beconsidered a greatest possible dimension measured according to theintended usage, while a “minimum extent” may be considered a smallestpossible dimension measured according to the intended usage. In someinstances, an “extent” may generally be measured orthogonally within aplane and/or cross-section, but may be, as will be apparent from theparticular context, measured differently—such as, but not limited to,angularly, radially, circumferentially (e.g., along an arc), etc.

The terms “monolithic” and “unitary” shall generally refer to an elementor elements made from or consisting of a single structure or baseunit/element. A monolithic and/or unitary element shall excludestructure and/or features made by assembling or otherwise joiningmultiple discrete elements together.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment(s) described may include a particular feature, structure, orcharacteristic, but every embodiment may not necessarily include theparticular feature, structure, or characteristic. Moreover, such phrasesare not necessarily referring to the same embodiment. Further, when aparticular feature, structure, or characteristic is described inconnection with an embodiment, it would be within the knowledge of oneskilled in the art to effect the particular feature, structure, orcharacteristic in connection with other embodiments, whether or notexplicitly described, unless clearly stated to the contrary. That is,the various individual elements described below, even if not explicitlyshown in a particular combination, are nevertheless contemplated asbeing combinable or arrangeable with each other to form other additionalembodiments or to complement and/or enrich the described embodiment(s),as would be understood by one of ordinary skill in the art.

For the purpose of clarity, certain identifying numerical nomenclature(e.g., first, second, third, fourth, etc.) may be used throughout thedescription and/or claims to name and/or differentiate between variousdescribed and/or claimed features. It is to be understood that thenumerical nomenclature is not intended to be limiting and is exemplaryonly. In some embodiments, alterations of and deviations frompreviously-used numerical nomenclature may be made in the interest ofbrevity and clarity. That is, a feature identified as a “first” elementmay later be referred to as a “second” element, a “third” element, etc.or may be omitted entirely, and/or a different feature may be referredto as the “first” element. The meaning and/or designation in eachinstance will be apparent to the skilled practitioner.

The occurrence of thrombi in the left atrial appendage (LAA) duringatrial fibrillation may be due to stagnancy of blood pooling in the LAA.The pooled blood may still be pulled out of the left atrium by the leftventricle, however less effectively due to the irregular contraction ofthe left atrium caused by atrial fibrillation. Therefore, instead of anactive support of the blood flow by a contracting left atrium and leftatrial appendage, filling of the left ventricle may depend primarily orsolely on the suction effect created by the left ventricle. However, thecontraction of the left atrial appendage may not be in sync with thecycle of the left ventricle. For example, contraction of the left atrialappendage may be out of phase up to 180 degrees with the left ventricle,which may create significant resistance to the desired flow of blood.Further still, most left atrial appendage geometries are complex andhighly variable, with large irregular surface areas and a narrow ostiumor opening compared to the depth of the left atrial appendage. Theseaspects as well as others, taken individually or in variouscombinations, may lead to high flow resistance of blood out of the leftatrial appendage.

In an effort to reduce the occurrence of thrombi formation within theleft atrial appendage and prevent thrombi from entering the blood streamfrom within the left atrial appendage, it may be desirable to developmedical devices and/or occlusive implants that close off the left atrialappendage from the heart and/or circulatory system, thereby lowering therisk of stroke due to thrombolytic material entering the blood streamfrom the left atrial appendage. Example medical devices and/or occlusiveimplants that close off the left atrial appendage are disclosed herein.

FIG. 1 illustrates an example occlusive implant 10. The occlusiveimplant 10 may include a first end region 12 and a second end region 14.As will be discussed in greater detail below, the first end region 12may include the portion of the occlusive implant 10 which extendsfarthest into a left atrial appendage, while the second end region 14may include the portion of the occlusive implant 10 which is positionedcloser to an opening of the left atrial appendage.

The occlusive implant 10 may include an expandable member 16. Theexpandable member 16 may also be referred to as an expandable balloon16. The expandable member 16 may be formed from a highly compliantmaterial (e.g., “inflation material”) which permits the expandablemember 16 to expand from a first unexpanded (e.g., deflated, collapsed,delivery) configuration to a second expanded (e.g., inflated, delivered)configuration. In some examples, the expandable balloon 16 may beinflated to pressures from about 4 psi to about 200 psi. It can beappreciated that the outer diameter of the implant 10 may be larger inthe expanded configuration versus the unexpanded configuration. Examplematerials used for the inflation material may be hydrogel beads (orother semi-solid materials), saline, etc.

In some examples, the inflatable member may be constructed from siliconeor a low-durometer polymer, however, other materials are contemplated.Additionally, the expandable member 16 may be impermeable to bloodand/or other fluids, such as water. In some embodiments, the expandablemember 16 may include a woven, braided and/or knitted material, a fiber,a sheet-like material, a metallic or polymeric mesh, or other suitableconstruction. Further, in some embodiments, the expandable member 16 mayprevent thrombi (e.g., blood clots, etc.) originating in the left atrialappendage from passing through the occlusive device 10 and into theblood stream. In some embodiments, the occlusive device 10 may promoteendothelial growth after implantation, thereby effectively removing theleft atrial appendage from the patient's circulatory system. Somesuitable, but non-limiting, examples of materials for the occlusivemember 10 are discussed below.

FIG. 1 further illustrates that occlusive member 10 may include one ormore spine members 18 extending along the longitudinal axis 50 of theexpandable member 16 from the second end region 14 to the first endregion 12. In some examples described herein, the spine members 18 maybe described as positioning members 18. Each of the spine members 18 mayinclude a first end 20 and a second end 22 (the second end 22 is shownin FIG. 2). FIG. 1 further illustrates that the each of the individualspine members 18 may be spaced apart from adjacent spine members 18. Inother words, the spacing between adjacent spine members 18 may besubstantially uniform around the circumference of the expandable member16. In some examples, the spine members 18 may include one or morematerials which are stiffer, higher durometer materials than thematerial utilized to construct the expandable member 16. Some suitable,but non-limiting, examples of materials for the spine members 18 arediscussed below.

Further, it is contemplated that in some instances the spacing betweenspine members 18 may not be uniform. In some examples, the spacingbetween adjacent spine members 18 may be variable (e.g., non-uniformlyspaced) around the circumference of the expandable member 16.Additionally, it is contemplated that the spine member 18 may form aframework in which the spine members 18 are connected to one another viaa series of laterally extending members. A variety of differentgeometries for example frameworks are contemplated.

As illustrated in FIG. 1, the first end region 12 of the expandablemember 16 may extend radially inward to form an apex region 33.Additionally, as shown in FIG. 1, each of the first end portions 20 ofeach of the spine members 18 may extend inward along the longitudinalaxis 50 toward the apex region 33 of the expandable member 16.

Additionally, FIG. 1 illustrates that the occlusive member 10 mayinclude a “nesting region” 26. The nesting region 26 may define aportion of the occlusive member 10 which is configured to nest within anopening of the left atrial appendage (as will be illustrated anddescribed further in FIG. 5). The nesting region 26 may include aportion of the occlusive member 10 which extends radially inward towardthe longitudinal axis 50 of the occlusive member 10. Further, the inwardcurve which defines the nesting region 26 may extend circumferentiallyaround the occlusive member 10. In other words, the inward curvature ofthe nesting region 26 may resemble a channel or groove which extendsaround the circumference of the occlusive member 10.

FIG. 1 further illustrates that the second end region 28 of theocclusive member 10 may include a coating 28. The coating 28 may extendaround the circumference of the occlusive member 10 (including both theexpandable member 16 and the spine members 18). In some examples, thecoating 28 may promote cellular growth along the surface thereof. Forexample, the coating 28 may include elements which promote endothelialgrowth along the surface thereof. For example, the endothelial growthelements may accelerate the ability for endothelial cellular tissue toform a seal across an opening of the left atrial appendage. In otherexamples, the coating 28 may include a polymer mesh (e.g., PET mesh), awoven, braided and/or knitted material, a fiber, a sheet-like material,a metallic or polymeric mesh, or other similar materials which may becoupled to the outer surface of the expandable member 16.

FIG. 2 illustrates a bottom view of the occlusive device described inFIG. 1. FIG. 2 illustrates that the occlusive device may include abottom surface 30. As discussed above, the second end regions 22 of thespine members 18 may “wrap” along (e.g., around) the second end region14 (shown in FIG. 1) and terminate along the bottom surface 30.

FIG. 2 further shows twelve spine members 18 positionedcircumferentially around the longitudinal axis 50 of the occlusivedevice 10. However, while FIG. 2 illustrates twelve spine members 18positioned around the longitudinal axis 50 of the occlusive device 10,it is contemplated that more greater or less than twelve spine members18 may be utilized for any example occlusive devices 10 contemplatedherein. For example, occlusive device 10 may include 1, 2, 3, 4, 5, 6,7, 8, 9, 10, 11, 12, 13, 14, 15, 16 or more spine members 18 positionedalong the occlusive device 10.

As will be described in greater detail below, FIG. 2 further illustratesa valve member 32 positioned in a central region of the bottom surface30 of the occlusive member 10. The valve 32 may be utilized as an accessaperture to insert a secondary medical device (not shown). The secondarymedical device may be utilized to inject a fluid material into theexpandable member 16. FIG. 2 further illustrates that the coating 28 maybe positioned along the bottom surface 30 of the occlusive device 10.The coating 28 may cover all or a portion of the bottom surface 30 ofthe occlusive device 10.

FIG. 3 shows a cross-sectional view along line 3-3 of FIG. 1. FIG. 3illustrates that the expandable member 16 may include an inner surface25 and outer surface 27. Additionally, FIG. 3 shows that the expandablemember 16 may include a wall thickness “X” defined as the width of thewall between the inner surface 25 and outer surface 27 of the expandablemember 16.

FIG. 3 further illustrates that the spine members 18 may be positionedwithin the wall of the expandable member 16. FIG. 3 illustrates thateach of the spine members 18 may include an inwardly-facing surface 29and an outwardly-facing surface 31. The inner surface 29 of each of thespine members 18 may be positioned radially outward of the inner surface25 of the expandable member 16. Further, the outer surface 31 of each ofthe spine members 18 may be positioned radially inward of the outersurface 27 of the occlusive member 10. In other words, each of the spinemembers 18 be embedded (e.g., encased, surrounded, etc.) within the wallof the expandable member 16. However, this is not intended to belimiting. Rather, it can be appreciated that in some examples, a portionof one or more of the spine members 18 may extend radially away from theouter surface 27 of the expandable member 16. For example, in someinstances a portion of the outer surface 31 of one or more of the spinemembers 18 may be free from the expandable member 16.

FIG. 3 further illustrates that the expandable member 16 may include aninner cavity 34. Inner cavity 34 may be described as a chamber in whichin an inflation media (e.g., hydrogel beads, semi-solid materials,saline or other suitable liquids, gases, etc.) may be injected (viavalve 32, for example) in order to expand the expandable member 16. Aswill be described in greater detail below, as an inflation media isinserted into the expandable member 16, the inner cavity 34 may expand,thereby permitting the expandable member 16 to seal against the tissuewalls defining an opening in the left atrial appendage.

As stated above, inflation of the inner cavity 34 may be accomplished byinserting inflation media through the valve 32. As shown in FIG. 2, thevalve 32 may be formed from the same material that forms the wall of theexpandable member 16. In other words, the valve 32 may be an extensionof the wall of the expandable member 16. Additionally, as illustrated inFIG. 3, the valve 32 may be positioned within the inner cavity 34. Forexample, FIG. 3 illustrates that the valve 32 may extend (e.g., project)into the inner cavity 34 from the bottom surface 30.

The valve 32 may include an inflation lumen 36 which may be designed toallow a secondary medical device to be inserted therethrough. As shownin FIG. 3, the inflation lumen 36 may be aligned with the longitudinalaxis 50 of the occlusive member 10. FIG. 3 shows the inflation lumen 36in a closed configuration such that it would prevent inflation media(not shown in FIG. 3) from passing back through the valve 32. As shownin FIG. 3, in some examples the valve 32 may be maintained in a closedconfiguration via a torus-shaped mechanical gasket 38. For simplicitypurposes, the gasket 38 may be referred to as an “O-ring” in theremaining discussion.

It can be appreciated that the O-ring 38 may be formed from a material(e.g., rubber, elastomer, etc.) which permits it to compress radiallyinwardly. As shown in FIG. 3, the O-ring 38 may be positioned around thevalve 32 such that the O-ring 38 compresses the lumen 36 of valve 32shut. However, the O-ring 38 must also permit the lumen 36 to openenough for a secondary medical device to be inserted therethrough (forinflation of the expandable member 16 as described above). Therefore, insome examples the O-ring 38 may designed to stretch and allow aninflation device access to the inner chamber 34 while also exertingsufficient radially inward force to maintain the lumen 36 in a closedconfiguration once the inner chamber 34 has been inflated and after theinflation device (not shown in FIG. 3) is removed from the lumen 36(inflation of the chamber 34 will be discussed with respect to FIG. 9and FIG. 10).

As will be discussed in greater detail below, the occlusive member 10may be coupled to a delivery system in a variety of ways. Further, acomponent of the delivery system may also function as a secondarymedical device utilized to inflate the expandable member 16. FIG. 3illustrates an attachment region 40 which may be utilized to attach thedelivery system to the occlusive member 10. Attachment region 40 may beinclude a variety of features which permit attachment to a deliverysystem. For example, attachment region 40 may include threads which matewith a threaded region on a delivery catheter (not shown in FIG. 3). Inother examples, the attachment region 40 may be designed such that itforms a “press-fit” with a distal end region of a delivery catheter.Other methods of attaching the occlusive device 10 to the deliverycatheter may include a ratcheting mechanism, break-away mechanisms,detent lock, spring lock, single-piece coupling, two-piece coupling, orcombinations thereof.

FIG. 4 illustrates a cross-sectional view of another example occlusivedevice 110. The occlusive device 110 may be similar in form and functionas the occlusive device 10. For example, the occlusive device 110 mayinclude an expandable member 116 and one or more spine members 118coupled thereto. Additionally, the occlusive device 110 may include avalve 132. The valve 132 illustrated in FIG. 4 may function in a similarmanner as the valve 32 described above. However, as illustrated in FIG.4, the valve 132 may include a flap 142 configured to mate with asupport member 144. It can be appreciated from FIG. 4 that in someinstances the flap 142 and the support member 144 may resemble a one-wayvalve system whereby the flap 142 is designed to permit inflation media(or an inflation device) to access an inner chamber 134 while preventinginflation media from exiting the inner chamber 134 once the expandablemember 116 has been inflated to a sufficient extent. In other words, theflap 142 may be designed to pivot counter-clockwise, thereby allowinglumen 136 to access the inner chamber 134 of the expandable member 116.

FIG. 5 illustrates that the occlusive implant 10 may be inserted andadvanced through a body lumen via an occlusive implant delivery system21. FIG. 5 further illustrates the occlusive implant 10 positionedwithin the left atrial appendage 60. As discussed above, in someinstances the occlusive implant 10 may be positioned within the leftatrial appendage such that the nesting region 26 is anchored within aportion of the left atrial appendage 60.

In some instances, an occlusive implant delivery system 21 may include adelivery catheter 24 which is guided toward the left atrium via variouschambers and lumens of the heart (e.g., the inferior vena cava, thesuperior vena cava, the right atrium, etc.) to a position adjacent theleft atrial appendage 60. The delivery system 21 may include a hubmember 23 coupled to a proximal region of the delivery catheter 24. Thehub member 23 may be manipulated by a clinician to direct the distal endregion of the delivery catheter 24 to a position adjacent the leftatrial appendage 60. As discussed above, a proximal end of the occlusivedevice 10 may be configured to releasably attach, join, couple, engage,or otherwise connect to the distal end of the delivery catheter 24. Insome embodiments, an end region of the occlusive device 10 may include athreaded insert coupled thereto. In some embodiments, the threadedinsert may be configured to and/or adapted to couple with, join to, matewith, or otherwise engage a threaded member disposed at the distal endof the delivery catheter 24. Other means of releasably coupling and/orengaging the proximal end of the occlusive device 10 to the distal endof the delivery catheter are also contemplated. Further, in someexamples the delivery catheter 24 may include an inflation lumen (notshow) designed to permit inflation media to pass into the occlusivedevice 10 (as described above). For example, in some examples, thedistal end of the delivery catheter 24 may include a needle designed tobe inserted through the valve 32 (discussed in FIG. 3).

FIGS. 6-8 illustrate the example occlusive device 10 (described above)being positioned and deployed in an opening of the left atrial appendage60. As discussed above, in some examples, the occlusive device 10 may beconfigured to shift between a collapsed configuration and an expandedconfiguration. For example, in some instances, the occlusive implant maybe in a collapsed configuration during delivery via an occlusive devicedelivery system, whereby the occlusive device expands to an expandedconfiguration once deployed from the occlusion implant delivery system.

FIG. 6 shows the occlusive device 10 including an expandable member 16,a plurality of spine members 18 and a cellular-growth promoting coating28 (as described above). Further, FIG. 6 illustrates that the occlusivemember 10 may be detachably coupled to a delivery catheter 24. Theocclusive member 10 shown in FIG. 6 may be described as being in adeflated or delivery configuration. In other words, the expandablemember 16 may not contain any inflation media within its inner cavity.It can be appreciated that it may be desirable to maintain the occlusivemember 10 in a collapsed configuration when delivering the occlusivemember 10 to the target site (e.g., an opening in the left atrialappendage 60). A collapsed configuration may permit the occlusive member10 to more easily track through tortuous vasculature as a cliniciandirects the device to the target site.

FIG. 7 illustrates an example first stage in deployment of the occlusivemember 10. FIG. 7 shows the expandable member 16 expanded to a largerdiameter as compared with the non-expanded configuration illustrated inFIG. 6. It can be appreciated that inflation media has been injectedinto the inner chamber of the expandable member 16, whereby theinflation media shifts the expandable member from the deflatedconfiguration (shown in FIG. 6) to the partially-inflated configurationshown in FIG. 7.

Additionally, FIG. 7 illustrates that as the expandable member 16inflates radially outward, the spine members 18 approach and may contactthe inner surface 62 (e.g., the tissue wall) of the left atrialappendage 60. It can be appreciated that as the spine members 18 (whichare circumferentially spaced around the expandable member 16) begin tocontact the inner surface 62 of the left atrial appendage 60, they maycenter and maintain the occlusive device 10 within the opening of theleft atrial appendage 60. Additionally, as the spine members 18 contactthe inner surface 62 of the atrial appendage 60 they may reduce thelikelihood that occlusive device 10 will shift its position within theleft atrial appendage 60. Additionally, when aligned properly, thenesting region 26 of the occlusive member 10 may nest within a portionof the wall of the left atrial appendage 60, thereby furthering reducingthe likelihood that the occlusive member 10 will shift its positionwhile in the partially deflated state shown in FIG. 7.

FIG. 8 illustrates the occlusive member 10 in a fully inflated state.Additionally, FIG. 8 illustrates that the expandable member 16 may becompliant and, therefore, substantially conform to and/or be in sealingengagement with the shape and/or geometry of a lateral wall 62 of a leftatrial appendage 60 while in the inflated (e.g., expanded)configuration. In some embodiments, the occlusive device 10 may expandto a size, extent, or shape different from a maximum unconstrainedextent, as determined by the surrounding tissue and/or lateral wall 62of the left atrial appendage 60.

As can be appreciated from FIG. 8, continued inflation of the expandablemember 16 beyond the partially inflated state shown in FIG. 7 may permitthe expandable member 16 to expand and conform to the specific geometryof the inner surface 62 of the left atrial appendage 60. In other words,as inflation media is added to the expandable member 16, the expandablemember 16 may fill and/or seal gaps in the opening of the left atrialappendage 60 which may not have been sealed while the occlusive device10 was partially inflated (as shown in FIG. 7). It can be appreciatedthat the flexible material used to construct the expandable member 16may stretch, conform and directly oppose the folded curvature of theinner surface 62 of the left atrial appendage 60. For example, FIG. 8shows the expandable member 16 expanded such that the expandable member16 is contacting the curved inner surface 62 of the left atrialappendage 60, thereby sealing the opening of the left atrial appendage60. Additionally, FIG. 8 illustrates the nesting region 26 of theocclusive member seated within a portion of the inner surface 62 of theleft atrial appendage 60.

It can further be appreciated from FIG. 8 that the bottom surface 30 ofthe occlusive device is positioned such that it is facing the leftatrium of the heart. As discussed above, the bottom surface 30 of theocclusive device 10 may include the cellular-growth promoting coating28. Accordingly, the cellular-growth promoting coating 28 is positionedto promote the growth of endothelial cellular tissue across the bottomsurface 30 of the occlusive implant 10, thereby effectively sealing theleft atrial appendage 60.

FIG. 9 and FIG. 10 show cross-sectional views of the occlusive device 10being inflated from a partially-inflated state (shown in FIG. 7) to afully inflated state (shown in FIG. 8.) whereby the expandable member 16fully opposes the inner surface 62 of the left atrial appendage 60. FIG.9 further illustrates a delivery catheter 24 (described above in someexamples as a secondary medical device) having been advanced through thelumen 36 of the valve 32. As described above, the O-ring 38 has expandedradially outward to permit the distal end region of the deliverycatheter 24 to be advanced through the valve lumen 36 and into the innerchamber 34 of the expandable member 16. Once positioned within the innerchamber 34, the inflation media (depicted by the arrows in FIG. 9) maybe injected into the inner chamber 34, thereby expanding the occlusivedevice 10 as described above.

FIG. 10 shows the occlusive device 10 deployed along the inner surface62 of the left atrial appendage 60. Further, FIG. 10 illustrates thedelivery catheter 24 described above in FIG. 9 having been removed fromthe inflation lumen 36 of the valve 32. It can be appreciated from FIG.10 that the O-ring 38 has been compressed radially inward such that ithas closed the lumen 36. It can be further appreciated that the O-ring38 may designed to exert sufficient radially inward force along thevalve 36 to prevent the inflation media from passing back through thevalve 32 (which may partially collapse the occlusive device 10).

FIG. 11 illustrates another example occlusive device 210. Occlusivedevice 210 may be similar in form and function to other occlusivedevices described above (e.g., occlusive device 10). Occlusive device210 may include an expandable member 216 including a first end region212 and a second end region 214. The expandable member 216 may besimilar in form and function to the expandable member 16 describedabove.

Occlusive device 210 may include a positioning member 218. Thepositioning member 218 may function similarly to the spine members 18described above. However, as illustrated in FIG. 11, the spine member218 may extend around the circumference of the expandable member 216.Further, the spine member 218 may include a plurality of curved portions220. In some examples, the spine member 218 may provide additionalradial support for the occlusive device 210. Additionally, in someexamples, the expandable member 216 may expand in the radial direction agreater distance than the spine member 218. The ability for theexpandable member 216 to expand farther (in the radial direction) thanthe spine member 218 may permit the expandable member 218 to conform tothe irregularly-shaped folds and curved surfaces of a left atrialappendage.

While not illustrated in FIG. 11, it is contemplated that the occlusivedevice 210 may include more than one expandable member 216. For example,the first end region 212 may include a first expandable member and thesecond end region 214 may include a second expandable member whichoperates independently of the first expandable member.

FIG. 12 illustrates another example occlusive device 310. Occlusivedevice 310 may be similar in form and function to other occlusivedevices described above (e.g., occlusive device 10). Occlusive device310 may include an expandable member 316 and a plurality of spinemembers 318 coupled thereto. Further, FIG. 12 illustrates that theocclusive device 310 may include a plurality of anchor members 364disposed along the expandable member 316. It can be appreciated that insome examples the occlusive device 310 may be affixed to a left atrialappendage by one or more anchoring members 364. For example, when theocclusive device 310 is positioned adjacent the inner surface of theleft atrial appendage (as shown in FIG. 8), the anchor members 364 mayextend radially outward from the expandable member 316 and contact thetissue of the left atrial appendage thereby anchoring the occlusiveimplant 310 in a fixed position.

In some embodiments, at least some of the anchor members 364 may includea base 368 and a tip portion 366 projecting radially away from the base368, as shown in FIG. 12. For example, the detailed view of FIG. 12illustrates the base 368 of anchor member 364 positioned along an innersurface of the expandable member 316. Further, FIG. 12 illustrates thetip portion 366 extending through the wall of the expandable member 316such that it extends away from the expandable member 316. In otherexamples, it is contemplated that the base 368 of the anchor members 364may be bonded directly to the outer surface of the expandable member316. Further, in other examples it is contemplated that the base 368 ofthe anchor members 364 may be bonded directly to a portion of the spinemembers 318.

FIG. 12 illustrates two anchor members 364 positioned along theocclusive device 310. However, this is not intended to be limiting.Rather, the occlusive device 310 may include 1, 2, 3, 4, 5, 6, 7, 8, 9,10, 11, 12, 13, 14, 15, 16 or more anchor members 364. Additionally, itis contemplated that an anchor member 364 may be positioned along aspine member 318. However, this is not intended to be limiting. Rather,it is contemplated that more than one anchor members 364 may be attachedto a single spine member 318. For example, a single spine member 318 mayinclude 1, 2, 3, 4, 5, 6, or more anchor members 364 attached thereto.

Additionally or alternatively, the occlusive device 310 may includefixation elements 370 disposed along the outer surface of expandablemember 316 and/or the spine members 318. Fixation elements 370 mayinclude one or more individual bristles 372 positioned adjacent oneanother. In some examples, the bristles made be formed from a metal(e.g., stainless steel), a polymer (e.g., polyester, etc.) orcombinations thereof. As illustrated in the detailed view in FIG. 12,the bristles may extend radially away from the outer surface of theexpandable member 316. Further, a plurality of the fixation elements 370may be positioned in a variety of locations along the occlusive member310. FIG. 12 illustrates six fixation elements 370 positioned along theocclusive device 310. However, this is not intended to be limiting.Rather, the occlusive device 310 may include 1, 2, 3, 4, 5, 6, 7, 8 ormore fixation elements 370. The fixation elements 370 may improve theability of the occlusive device 310 to grip and maintain its positionwhen positioned within the left atrial appendage.

FIG. 13 illustrates another example occlusive device 410. The occlusivedevice 410 may be similar in form and function as the occlusive device10 described above. For example, the occlusive device 410 may include anexpandable member 416 and one or more spine members 418 coupled thereto.The expandable member 416 may be formed from a highly compliant material(e.g., “inflation material”) which permits the expandable member 416 toexpand from a first unexpanded (e.g., deflated, collapsed) configurationto a second expanded (e.g., inflated) configuration (as described abovewith respect to the occlusive device 10).

As discussed above, FIG. 13 illustrates that occlusive member 410 mayinclude one or more spine members 418 extending along the longitudinalaxis 50 of the expandable member 416 from the second end region 414 tothe first end region 412. In some examples described herein, the spinemembers 418 may be described as positioning members 418. Each of thespine members 418 may include a first end 420 disposed along the firstend region 412 and a second end (not shown in FIG. 13) disposed alongthe bottom surface (not shown in FIG. 13) of the occlusive member 410.FIG. 13 further illustrates that the each of the individual spinemembers 418 may be spaced apart from adjacent spine members 418. Inother words, the spacing between adjacent spine members 418 may besubstantially uniform around the circumference of the expandable member416. In some examples, the spine members 418 may include one or morematerials which are stiffer, higher durometer materials than thematerial for which the expandable member 416 is constructed. Somesuitable, but non-limiting, examples of materials for the spine members418 are discussed below.

As illustrated in FIG. 13, the first end region 412 (including spinemembers 418) of the expandable member 416 may extend radially inward toform an apex region 433. Additionally, as shown in FIG. 13, each of thefirst end portions 420 of each of the spine members 418 may extendinward along the longitudinal axis 50 toward the apex region 433 wherebyeach of the first end portions 420 of the spine members 418 may combine(e.g., engage, affix, attach, etc.) with one another to form the apexregion 433. It can be appreciated that combining the first end portions420 of each of the spine members to one another may limit the elongationof the occlusive implant 410 along the longitudinal axis 50 when theocclusive implant 410 shifts from an unexpanded configuration to anexpanded configuration (as described above). In other words, when thefirst end portions 420 of each of the spine members 418 are attached toone another, they may work together to resist the longitudinalelongation imparted by the expandable member 416 along the longitudinalaxis 50 of the occlusive implant 410 when the occlusive implant 410shifts from an unexpanded configuration to an expanded configuration (asdescribed above).

FIG. 13 further illustrates that the second end region 414 of theocclusive member 410 may include a coating 428. The coating 428 mayextend around the circumference of the occlusive member 410 (includingboth the expandable member 416 and the spine members 418). In someexamples, the coating 428 may promote cellular growth along the surfacethereof. For example, the coating 428 may include elements which promoteendothelial growth along the surface thereof. For example, theendothelial growth elements may accelerate the ability for endothelialcellular tissue to form a seal across an opening of the left atrialappendage. In other examples, the coating 428 may include a polymer mesh(e.g., PET mesh) or similar covering which may be attached to the outersurface of the occlusive member 410.

Additionally, FIG. 13 illustrates that the occlusive member 410 mayinclude a “nesting region” 426. The nesting region 426 may define aportion of the occlusive member 410 which is configured to nest withinan opening of the left atrial appendage. The nesting region 426 mayinclude a portion of the occlusive member 10 which extends radiallyinward toward the longitudinal axis 50 of the occlusive member 410.Further, the inward curve which defines the nesting region 426 mayextend circumferentially around the occlusive member 410. In otherwords, the inward curvature of the nesting region 426 may resemble achannel or groove which extends around the circumference of theocclusive member 410.

FIG. 14 shows a top view of the occlusive member 410 shown in FIG. 13.Specifically, FIG. 14 illustrates the first end portions 420 of thespine members 418 extending radially inward to form the apex region 433.As discussed above, while FIG. 14 illustrates the spine members 418being evenly spaced from one another, it can be appreciated that thespine members 418 may be spaced at unequal intervals from one another.

The materials that can be used for the various components of theocclusive implant 10 (and variations, systems or components thereofdisclosed herein) and the various elements thereof disclosed herein mayinclude those commonly associated with medical devices. For simplicitypurposes, the following discussion makes reference to the occlusiveimplant 10 (and variations, systems or components disclosed herein).However, this is not intended to limit the devices and methods describedherein, as the discussion may be applied to other elements, members,components, or devices disclosed herein.

In some embodiments, the occlusive implant 10 (and variations, systemsor components thereof disclosed herein) may be made from a metal, metalalloy, polymer (some examples of which are disclosed below), ametal-polymer composite, ceramics, combinations thereof, and the like,or other suitable material. Some examples of suitable metals and metalalloys include stainless steel, such as 444V, 444L, and 314LV stainlesssteel; mild steel; nickel-titanium alloy such as linear-elastic and/orsuper-elastic nitinol; other nickel alloys such asnickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL®625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such asHASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copperalloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS®400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g.,UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys,other nickel-molybdenum alloys, other nickel-cobalt alloys, othernickel-iron alloys, other nickel-copper alloys, other nickel-tungsten ortungsten alloys, and the like; cobalt-chromium alloys;cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®,PHYNOX®, and the like); platinum enriched stainless steel; titanium;platinum; palladium; gold; combinations thereof; and the like; or anyother suitable material.

As alluded to herein, within the family of commercially availablenickel-titanium or nitinol alloys, is a category designated “linearelastic” or “non-super-elastic” which, although may be similar inchemistry to conventional shape memory and super elastic varieties, mayexhibit distinct and useful mechanical properties. Linear elastic and/ornon-super-elastic nitinol may be distinguished from super elasticnitinol in that the linear elastic and/or non-super-elastic nitinol doesnot display a substantial “superelastic plateau” or “flag region” in itsstress/strain curve like super elastic nitinol does. Instead, in thelinear elastic and/or non-super-elastic nitinol, as recoverable strainincreases, the stress continues to increase in a substantially linear,or a somewhat, but not necessarily entirely linear relationship untilplastic deformation begins or at least in a relationship that is morelinear than the super elastic plateau and/or flag region that may beseen with super elastic nitinol. Thus, for the purposes of thisdisclosure linear elastic and/or non-super-elastic nitinol may also betermed “substantially” linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may alsobe distinguishable from super elastic nitinol in that linear elasticand/or non-super-elastic nitinol may accept up to about 2-5% strainwhile remaining substantially elastic (e.g., before plasticallydeforming) whereas super elastic nitinol may accept up to about 8%strain before plastically deforming. Both of these materials can bedistinguished from other linear elastic materials such as stainlesssteel (that can also be distinguished based on its composition), whichmay accept only about 0.2 to 0.44 percent strain before plasticallydeforming.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy is an alloy that does not show anymartensite/austenite phase changes that are detectable by differentialscanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA)analysis over a large temperature range. For example, in someembodiments, there may be no martensite/austenite phase changesdetectable by DSC and DMTA analysis in the range of about −60 degreesCelsius (° C.) to about 120° C. in the linear elastic and/ornon-super-elastic nickel-titanium alloy. The mechanical bendingproperties of such material may therefore be generally inert to theeffect of temperature over this very broad range of temperature. In someembodiments, the mechanical bending properties of the linear elasticand/or non-super-elastic nickel-titanium alloy at ambient or roomtemperature are substantially the same as the mechanical properties atbody temperature, for example, in that they do not display asuper-elastic plateau and/or flag region. In other words, across a broadtemperature range, the linear elastic and/or non-super-elasticnickel-titanium alloy maintains its linear elastic and/ornon-super-elastic characteristics and/or properties.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy may be in the range of about 50 to about 60 weightpercent nickel, with the remainder being essentially titanium. In someembodiments, the composition is in the range of about 54 to about 57weight percent nickel. One example of a suitable nickel-titanium alloyis FHP-NT alloy commercially available from Furukawa Techno Material Co.of Kanagawa, Japan. Other suitable materials may include ULTANIUM™(available from Neo-Metrics) and GUM METAL™ (available from Toyota). Insome other embodiments, a superelastic alloy, for example a superelasticnitinol can be used to achieve desired properties.

In at least some embodiments, portions or all of the occlusive implant10 (and variations, systems or components thereof disclosed herein) mayalso be doped with, made of, or otherwise include a radiopaque material.Radiopaque materials are understood to be materials capable of producinga relatively bright image on a fluoroscopy screen or another imagingtechnique during a medical procedure. This relatively bright image aidsa user in determining the location of the occlusive implant 10 (andvariations, systems or components thereof disclosed herein). Someexamples of radiopaque materials can include, but are not limited to,gold, platinum, palladium, tantalum, tungsten alloy, polymer materialloaded with a radiopaque filler, and the like. Additionally, otherradiopaque marker bands and/or coils may also be incorporated into thedesign of the occlusive implant 10 (and variations, systems orcomponents thereof disclosed herein). to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MM)compatibility is imparted into the occlusive implant 10 (and variations,systems or components thereof disclosed herein). For example, theocclusive implant 10 (and variations, systems or components thereofdisclosed herein) and/or components or portions thereof, may be made ofa material that does not substantially distort the image and createsubstantial artifacts (e.g., gaps in the image). Certain ferromagneticmaterials, for example, may not be suitable because they may createartifacts in an MRI image. The occlusive implant 10 (and variations,systems or components disclosed herein) or portions thereof, may also bemade from a material that the MM machine can image. Some materials thatexhibit these characteristics include, for example, tungsten,cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®,PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g.,UNS: R44035 such as MP35-N® and the like), nitinol, and the like, andothers.

In some embodiments, the occlusive implant 10 (and variations, systemsor components thereof disclosed herein) and/or portions thereof, may bemade from or include a polymer or other suitable material. Some examplesof suitable polymers may include copolymers,polyisobutylene-polyurethane, polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP),polyoxymethylene (POM, for example, DELRIN® available from DuPont),polyether block ester, polyurethane (for example, Polyurethane 85A),polypropylene (PP), polyvinylchloride (PVC), polyether-ester (forexample, ARNITEL® available from DSM Engineering Plastics), ether orester based copolymers (for example, butylene/poly(alkylene ether)phthalate and/or other polyester elastomers such as HYTREL® availablefrom DuPont), polyamide (for example, DURETHAN® available from Bayer orCRISTAMID® available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), Marlex high-density polyethylene, Marlexlow-density polyethylene, linear low density polyethylene (for exampleREXELL®), polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polytrimethylene terephthalate, polyethylenenaphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI),polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide(PPO), poly paraphenylene terephthalamide (for example, KEVLAR®),polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMSAmerican Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinylalcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, polyurethane silicone copolymers (forexample, ElastEon® from Aortech Biomaterials or ChronoSil® fromAdvanSource Biomaterials), biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments, the sheath can be blendedwith a liquid crystal polymer (LCP). For example, the mixture cancontain up to about 6 percent LCP.

In some embodiments, the occlusive implant 10 (and variations, systemsor components thereof disclosed herein) may include a textile material.Some examples of suitable textile materials may include synthetic yarnsthat may be flat, shaped, twisted, textured, pre-shrunk or un-shrunk.Synthetic biocompatible yarns suitable for use in the present disclosureinclude, but are not limited to, polyesters, including polyethyleneterephthalate (PET) polyesters, polypropylenes, polyethylenes,polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides,naphthalene dicarboxylene derivatives, natural silk, andpolytetrafluoroethylenes. Moreover, at least one of the synthetic yarnsmay be a metallic yarn or a glass or ceramic yarn or fiber. Usefulmetallic yarns include those yarns made from or containing stainlesssteel, platinum, gold, titanium, tantalum or a Ni—Co—Cr-based alloy. Theyarns may further include carbon, glass or ceramic fibers. Desirably,the yarns are made from thermoplastic materials including, but notlimited to, polyesters, polypropylenes, polyethylenes, polyurethanes,polynaphthalenes, polytetrafluoroethylenes, and the like. The yarns maybe of the multifilament, monofilament, or spun-types. The type anddenier of the yarn chosen may be selected in a manner which forms abiocompatible and implantable prosthesis and, more particularly, avascular structure having desirable properties.

In some embodiments, the occlusive implant 10 (and variations, systemsor components thereof disclosed herein) may include and/or be treatedwith a suitable therapeutic agent. Some examples of suitable therapeuticagents may include anti-thrombogenic agents (such as heparin, heparinderivatives, urokinase, and PPack (dextrophenylalanine proline argininechloromethylketone)); anti-proliferative agents (such as enoxaparin,angiopeptin, monoclonal antibodies capable of blocking smooth musclecell proliferation, hirudin, and acetylsalicylic acid);anti-inflammatory agents (such as dexamethasone, prednisolone,corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine);antineoplastic/antiproliferative/anti-mitotic agents (such aspaclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine,epothilones, endostatin, angiostatin and thymidine kinase inhibitors);anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine);anti-coagulants (such as D-Phe-Pro-Arg chloromethyl keton, an RGDpeptide-containing compound, heparin, anti-thrombin compounds, plateletreceptor antagonists, anti-thrombin antibodies, anti-platelet receptorantibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, andtick antiplatelet peptides); vascular cell growth promoters (such asgrowth factor inhibitors, growth factor receptor antagonists,transcriptional activators, and translational promoters); vascular cellgrowth inhibitors (such as growth factor inhibitors, growth factorreceptor antagonists, transcriptional repressors, translationalrepressors, replication inhibitors, inhibitory antibodies, antibodiesdirected against growth factors, bifunctional molecules consisting of agrowth factor and a cytotoxin, bifunctional molecules consisting of anantibody and a cytotoxin); cholesterol-lowering agents; vasodilatingagents; and agents which interfere with endogenous vascoactivemechanisms.

While the discussion above is generally directed toward an occlusiveimplant for use in the left atrial appendage of the heart, theaforementioned features may also be useful in other types of medicalimplants where a fabric or membrane is attached to a frame or supportstructure including, but not limited to, implants for the treatment ofaneurysms (e.g., abdominal aortic aneurysms, thoracic aortic aneurysms,etc.), replacement valve implants (e.g., replacement heart valveimplants, replacement aortic valve implants, replacement mitral valveimplants, replacement vascular valve implants, etc.), and/or other typesof occlusive devices (e.g., atrial septal occluders, cerebral aneurysmoccluders, peripheral artery occluders, etc.). Other useful applicationsof the disclosed features are also contemplated.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of thedisclosure. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The disclosure's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A medical device for occluding the left atrialappendage, comprising: an expandable member having a first end region, asecond end region and an inflation cavity; a plurality of spine memberscoupled to the expandable member, the plurality of spine members spacedcircumferentially around an outer surface of the expandable member; anda valve member extending at least partially into the inflation cavity;wherein the plurality of spine members are configured to position themedical device within an opening of the left atrial appendage; whereinthe expandable member is configured to expand and seal the opening ofthe left atrial appendage; wherein at least a portion of each of thespine members extends at least partially inside a wall of the expandablemember.
 2. The medical device of claim 1, wherein each of the spinemembers extends along a longitudinal axis of the medical device from thefirst end region to the second end region.
 3. The medical device ofclaim 2, wherein the second end region includes a bottom surface andwherein at least a portion of each of the spine members is positionedalong the bottom surface.
 4. The medical device of claim 2, wherein theexpandable member includes a curved portion extending radially inwardtoward the longitudinal axis, and wherein the curved portion isconfigured to nest with the opening of the left atrial appendage.
 5. Themedical device of claim 1, wherein a portion of each of the spinemembers is positioned along an outer surface of the expandable member.6. The medical device of claim 1, wherein the first end region of theexpandable member extends toward a longitudinal axis of the medicaldevice to form an apex.
 7. The medical device of claim 1, wherein thesecond end region includes a coating, and wherein the coating isdesigned to promote endothelial cell growth.
 8. The medical device ofclaim 1, further comprising a fixation member configured to anchor themedical device to a target tissue site of the left atrial appendage. 9.The medical device of claim 8, wherein the fixation member includes aplurality of bristles projecting away from an outer surface of theexpandable member.
 10. The medical device of claim 8, wherein thefixation member includes a barb projecting away from an outer surface ofthe expandable member.
 11. A medical device for occluding the leftatrial appendage, comprising: an expandable balloon including an outersurface and an inner expansion cavity; a plurality of positioningmembers coupled to the expandable balloon; a fixation member extendingaway from the outer surface of the expandable balloon; wherein theplurality of positioning members are configured to position the medicaldevice within an opening of the left atrial appendage; wherein theexpandable balloon is configured to expand and seal the opening of theleft atrial appendage; wherein each of the positioning members isembedded within a wall of the balloon.
 12. The medical device of claim11, wherein each of the positioning members extends along a longitudinalaxis of the balloon from a first end region of the balloon to a secondend region of the balloon.
 13. The medical device of claim 12, whereinthe second end region of the balloon includes a bottom surface andwherein at least a portion of each of the positioning members ispositioned along the bottom surface.
 14. The medical device of claim 12,wherein the second end region includes a coating, and wherein thecoating is designed to promote endothelial cell growth.
 15. The medicaldevice of claim 11, wherein the fixation member includes a plurality ofbristles projecting away from an outer surface of the balloon.
 16. Themedical device of claim 11, wherein the fixation member includes a barbprojecting away from an outer surface of the balloon.
 17. A method forsealing the left atrial appendage, the method comprising: advancing anexpandable occluder to a position adjacent the left atrial appendage,wherein the expandable occluder includes: an expandable balloonincluding an inflation cavity; a plurality of spine members at least aportion of each of the spine members being embedded within surrounded bya wall of the balloon, wherein the spine members are spacedcircumferentially around an outer surface of the expandable balloon; anda valve member extending at least partially into the inflation cavity;inserting a tubular member into the valve; passing an inflation mediathrough the tubular member into the valve; and inflating the expandablemember to a first position such that the plurality of spine membersposition the occluder within an opening of the left atrial appendage.18. The method of claim 17, further comprising: inflating the expandablemember to a second position in which the expandable member seals againstan inner surface of the left atrial appendage.
 19. The method of claim17, wherein the wall is defined by an outer surface and an innersurface, wherein the inner surface forms the inflation cavity.